Ravulizumab-Cwvz to Be Evaluated for Severe COVID-19 in Phase 3 Trial
A phase 3 study evaluating Ultomiris (ravulizumab-cwvz; Alexion) in hospitalized patients with COVID-19 is expected to begin in May.
A phase 3 study evaluating Ultomiris (ravulizumab-cwvz; Alexion) in hospitalized patients with COVID-19 is expected to begin in May.
The FDA has granted Fast Track designation to MRT5005, an inhaled messenger RNA (mRNA) therapeutic being investigated for the treatment of cystic fibrosis.
Remunity is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial hypertension in patients ≥22 years of age.
The FDA has granted Orphan Drug designation to ARV-1801 (sodium fusidate; Arrevus) for the treatment of pulmonary exacerbations in patients with cystic fibrosis.
The FDA has granted 510(k) clearance to the Hyperfine system, a bedside magnetic resonance imaging system.
The FDA has accepted for review a supplemental New Drug Application for Recarbrio™, to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia.
The FDA has issued a safety communication informing healthcare providers, facilities, and patients about cybersecurity vulnerabilities associated with certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
The Food and Drug Administration has granted Fast Track designation to NanoFlu (Novavax) for seasonal influenza vaccination in adults ≥65 years.
Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
The FDA is reminding consumers not to use drugs, dietary supplements or medical device products distributed by Basic Reset or Biogenyx.